NCT01296269

Brief Summary

The purpose of this study is to investigate the role of a one-time intranasal administration of the oxytocin, vasopressin, or placebo on prosocial decision making such as cooperation and altruism in a healthy population of student controls.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 3, 2011

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 15, 2011

Completed
2 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Last Updated

April 8, 2011

Status Verified

April 1, 2011

Enrollment Period

1.1 years

First QC Date

February 3, 2011

Last Update Submit

April 7, 2011

Conditions

Keywords

social cognitionoxytocinvasopressindecision makingsocial decision making

Outcome Measures

Primary Outcomes (1)

  • allocations of monetary units

    Participants will make decisions regarding the allocation of monetary units between themselves and other participants. We will measure the quantity of monetary units kept for themselves vs. given to other participants

    approximately 45 minutes after intranasal administration of vasopressin, oxytocin, or placebo

Secondary Outcomes (1)

  • mood as measured via the visual analog scale

    approximately one hour and fifteen minutes after administration of oxytocin, vasopressin or placebo

Study Arms (3)

Vasopressin

EXPERIMENTAL

vasopressin condition

Drug: Arginine Vasopressin

oxytocin

EXPERIMENTAL

oxytocin condition (syntocinon)

Drug: Oxytocin

placebo

PLACEBO COMPARATOR
Drug: placebo

Interventions

one-time intranasal administration, 24 International Units, 5 puffs for each nostril

Also known as: syntocinon
oxytocin

one-time intranasal administration, 20 International Units, 5 puffs in each nostril

Vasopressin

contains all the ingredients as in the oxytocin and vasopressin conditions, save for the active ingredient, one time intranasal administration, 5 puffs in each nostril

placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy controls

You may not qualify if:

  • Past or present psychiatric, neurological, endocrinological or severe chronic medical illness.
  • Use of medications or drugs that would interfere with study results. This includes steroids, medications for psychiatric symptoms like anxiety or depression, stimulants, and medications for high blood pressure. Participants will be asked to tell the investigators of any medications or drugs that they are taking. The investigators will consider the drug interactions with oxytocin and vasopressin prior to study, and participants will not be able to participate in the study if the drug interactions could be dangerous.
  • history of drug or alcohol addiction
  • Pregnancy or Nursing Status: Because of the risk to an unborn fetus or infant, women who are pregnant or nursing are excluded from this protocol. All females will have a pregnancy test performed no more than 24 hours before each drug administration and will not be able to participate if the pregnancy test is positive.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hadassah University Medical Organization

Jerusalem, Jerusalem, Israel

RECRUITING

MeSH Terms

Conditions

Diabetes Insipidus

Interventions

OxytocinArginine Vasopressin

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesPituitary DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Pituitary Hormones, PosteriorPituitary HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsPeptidesAmino Acids, Peptides, and ProteinsVasopressinsNeuropeptidesOligopeptidesNerve Tissue ProteinsProteins

Study Officials

  • David Mankuta, MD

    Hadassah University Medical Organization

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 3, 2011

First Posted

February 15, 2011

Study Start

April 1, 2011

Primary Completion

May 1, 2012

Last Updated

April 8, 2011

Record last verified: 2011-04

Locations